Professor Cook, Chair of Medicine at St. Vincent’s Hospital, has supervised a coalition of scientists, neurologists, engineers, and specialists from around the globe (more than a hundred minds, in fact) in developing a medical implant that can be placed under the scalp, to capture data from brainwaves. Using a phone app, the data is stored in the Cloud to provide information that can help to forecast seizures. His project has reached a critical stage in its development and will soon be used in trials on humans. Driving innovation at the highest level of scientific endeavor, the good doctor talked about the risks in trying to commercialise a project of this scope, and the challenges of building the right team to move it forward.

It all started about 14 years ago when Professor Cook, some engineers, and a PhD student began research using animal data and short-term human electroencephalogram (EEG) recordings.

“It wasn’t possible to get long-term human recordings because the electrodes couldn’t stay on the scalp for longer than a few days. We figured out it was possible to predict seizures in principle, but in practice it was impossible. We had no way of attaching the implant to a human brain for any meaningful length of time to collect the data we needed, and you need a lot of data to make the prediction accurate.”After attending international meetings about seizure prediction, a company approached the small team with a solution, of sorts.

“It was something that could be implanted for a long-term period, maybe for years. It was very exciting.”

A major hurdle, however, was an invasive operation to attach it directly onto the brain.

“It also had a metal box that was implanted underneath the collarbone. It was a bit like putting a pacemaker into someone, it was quite a big ordeal.”

In addition to technical and operational difficulties, financial obstacles were proving insurmountable.

“We couldn’t get funding for long-term research. Then the company who made the system collapsed.”

Innovation proved the answer to challenges along the way

Professor Cook set his team to work making a smaller system in order to keep the research moving forward.

“We had it on the skin but the signal was not high enough quality, and we needed a better quality signal. So we made a device which goes under the skin, and with a small operation it can live permanently there recording the EEGs continuously.”

Innovation and risk management necessarily worked in tandem due to the nature of the pioneering research. Developing a less invasive system made a big difference.

“It’s now fitted in a way so we can monitor seizures and use the data from the brainwaves to predict them and understand how treatments are affecting them.”

Professor Cook and his collaborators are negotiating the final stages of an agreement with an Australian manufacturer to build the implants on shore.

“We hope to start a trial for putting them into patients at St. Vincent’s Hospital here in Melbourne, in 2018.”

Building the right team was critical to developing ‘The Minder’

“To manage a project of this size, you need a big team of engineers, neurologists, EEG technicians. As well as this, you need commercial people to deal with the patents and all the legal aspects. There are regulations and ultimately a need to sell it overseas, so international regulatory officers and the FDA are involved, and experts to negotiate with them. Identifying people with the right skills was hard at first because a lot of these were people we don’t normally do work with. You need to find people who are interested in your project, and interested in investing in it.”

Professor Mark assembled the team and got them to work together… “in a situation often constrained by some pretty significant cash issues.”

Goodwill and clarity helped people to work towards a common goal

Getting such a large number of collaborators to work effectively required everyone to understand their role to ensure their work was aligned with the overall vision.

“People were working in different organisations. Getting organisations to work together can be challenging, particularly when it comes to legal agreements. There are always matters to be decided around ownership and IP, and they can be very significant obstacles if not handled well. It takes a great deal of goodwill and clarity on the part of all participants for exactly who is doing what, and what our ultimate ambition is.”

Exploring how risk management and innovation work together in a collaborative, start-up working environment, some industry experts (steeped in risk management and innovation development at Accenture) identified three principles that support a better balance of the two disciplines, if applied to a collaborative workplace. Flexibility, speed, and control are key factors that can assist an organisation’s ability to strike the right chord.

Professor Cook’s team has likely undergone changes over 14 years, but the collaborative effort to move forward with the project has surely led to the creation of a new paradigm from which people living with epilepsy can hope for managing their lives with less risk. Even the manufacture of the implant and the app take an alliance of like-minded organisations. Cook says three main parties will own the technology with the manufacturers.

“Three main parties will own the technology,” explains Cook. “These three leading organisations are the hospital, the university and the Bionics Institute. I work for the University and through the Neurology Department of the hospital my clinical work is almost exclusively in the field of epilepsy, and the Bionics Institute is where a lot of our collaborators are based.”

Steve Culp, in an article on Leadership for Forbes, called on large organisations to consider the strategy of venture capital firms who generally create several investments with the expectation that some will fail. Being flexible by having multiple projects in development makes more sense than ‘placing all their bets on one or two experiments, companies may want to consider building a portfolio of early innovation investments that act as options’. Regularly assessing value against variables can provide important analysis for predicting outcomes. Rapid experimentation using iterative processes supports a faster results-based portfolio, because decisions around risks are made quickly. Where venture capital firms thrive is in applying controls encouraging innovation to develop in a safe space, and where investment and process merge creating a higher risk appetite enabling teams to learn from mistakes. The more people can recognise insights through mistakes, the more likely they will be to take risks and manage them in ways that maximise the opportunities for innovation.

Professor Cook’s team has likely undergone changes over 14 years, but the collaborative effort to move forward with the project has surely led to the creation of a new paradigm from which people living with epilepsy can hope for managing their lives with less risk. Even the manufacture of the implant and the app take an alliance of like-minded organisations. Cook says three main parties will own the technology with the manufacturers.

“Three main parties will own the technology,” explains Cook. “These three leading organisations are the hospital, the university and the Bionics Institute. I work for the University and through the Neurology Department of the hospital my clinical work is almost exclusively in the field of epilepsy, and the Bionics Institute is where a lot of our collaborators are based.”

A competitive outlook helped to sustain development through testing times

“The government supported us through the grant system for medical research early on. Also, I competed in an international competition and a shark tank event in Miami a couple of years ago, and we got a good amount of money from that which allowed us to keep employing people.”

“The main risk was that we didn’t have enough money to keep everybody employed and working on the project. That was the main risk at the start, for the project to be financially compromised, and that’s always a hazard with large projects.”

Managing risk effectively takes a certain frame of mind

“There were other risks around putting these devices in, but we figured we could do a lot of work testing them in sheep. We determined they were safe to put into humans and could be used safely for the long-term. The risks in trying to commercialise this are enormous, especially when you are trying to secure information around development. We have secure systems in place, and have not had any concerns over cyber security.”

Directing organisations to work together to achieve a common goal meant managing the complexity of decision-making, while allowing enough autonomy to support the process of research. Given the project’s objective it was a risk worth taking that led to a number of important scientific breakthroughs.

The future of epilepsy management

“The EEG captures the data, sends it to the Cloud and then we analyse whether or not there is seizure activity.”

‘The Minder,’ or the fitbit for the brain as it is fondly referred to, not only monitors and predicts seizure activity, it presents opportunities for better epilepsy management through medication adjustment. Life transforming technology really is innovation in its most radical form.

Definition

Minder = Minimally Invasive Neural Diagnostic Event Recorder

Nicknamed ‘FitBit for the brain’

About Professor Mark Cook MBBS (Melbourne), MD (London)

Currently Chair of Medicine at St. Vincent’s Hospital, Professor Cook specialises in the treatment of epilepsy and his previous role was also at St Vincent’s as Professor and Director of Neurology. He is recognised internationally for his expertise in epilepsy management, particularly imaging and surgical planning, and a pioneer of research and development of the world’s first medical implant that could help to forecast epileptic seizures. He worked as Brain Research Fellow at Queen Square, London, and at St. Vincent’s Hospital, Melbourne and has directed both the research and clinical components of the Neurology Department at St Vincent’s which have been significantly enlarged. Currently one of the largest units in Australia for the surgical treatment of epilepsy, this was a direct extension of work he began in London, where he developed techniques for the accurate measurement of hippocampal volumes, and established their position in non-invasive assessment of surgical candidates. More recently his interests have included experimental models of epilepsy and seizure prediction.

An integral member of CCI’s Risk Support team, Chris is a Risk Consultant with nearly 15 years of service at CCI. He supports Catholic Schools and education offices across the country, helping to reduce risk profiles and incidents of injury or property. He provides technical risk and compliance advice, and applies his skills across different areas of the business in ways that support, meet challenges, and offer tactical and strategic solutions for the Parish, Education and Social Welfare/Community Care sectors of the Church.